Pluri-compartment packaging and dispensing container for hypodermic injection ingredients



July 3, 1951 SEEMAR 2,559,231

I-COMPARTMENT PACKAGI PLUR NG AND DISPENSING CONTAINER FOR HYPODERMICINJECTION INGREDIENTS Filed Dec. 13, 1949 4,775 277,7170JJIIIIIIIIIJIIIJWIIJ 1a ff 4 Patented July 3, 1951 UNITED s'r'resDISPENSING CONTAINER FOR HYPO- DERMIC INJECTION INGREDIENTS George H.Seemar, Chatham, N. J.

Application December 13, 1949, Serial No. 132,648

15 Claims. '5

The invention relates in general to pharmaceutical accessories and hasparticular reference to aseptic packaging containers for medicamentsthat are administered by hypodermic injection. Narcotic drugs and othermedicaments that are to be administered by use of a hypodermic syringeusually are preserved in their free state separate from the liquidvehicle therefor until a time immediately preceding actualadministration of the injection. At that time, the medicament isdissolved in its appropriate vehicle to form the final injectionsolution, which in consequence of this procedure will be fresh and ofmaximum potency.

The particular manner in which the medicament and its related solventvehicle are separately packaged depends upon the type of hypodermicsyringe that is to be used. There is a specially constructed,complicated type of syringe that is adapted to be loaded internally witha multi-compartment cartridge or ampule in which the several ingredientsof a hypodermic injection charge are separately stored. My improvedpackaging container, although similar in some respects to the cartridgesfor syringes of that type, is not to be confused with such cartridges.The hypodermic syringe with which my invention is concerned is of thecommonly used, conventional type which has a single reservoir into whicha charge of the prepared injection solution is sucked, by a plungeroperating in the reservoir, through the usual hollow needle formomentary storage preceding the actual injection treatment, which latterinvolves employment of the same needle and reverse motion of theplunger.

In accordance with the old practice, each narcotic drug or othermedicament, which generally is in a dry and solid state, is packaged ina container that is separate and distinct from the container in whichthe liquid vehicle is packaged. Usually these separate containers havebeen in the form of small bottles having puncturable sealing caps fortheir filling openings. In effecting a mixture of the respectivecontents of any two related bottles, the needle of the hypodermicsyringe is first inserted into the bottle containing the vehicle throughits puncturable cap. After sucking the liquid contents of that bottleinto the syringe reservoir by plunger action, the needle must bewithdrawn from the bottle cap and moved through the outside air beforethe next operational step, which is insertion of the needle through thecap of the related bottle containing the medicament. The solvent is thenexpelled by plunger action from the syringe reservoir into themedicament bottle and is caused to take up 2 the medicament in solutionby imparting shaking motion to the bottle and syringe in their unitedcondition. Thereafter, the solution is sucked into the syringe reservoirand the needle is withdrawn through the bottle cap.

The use of separate bottles for the ingredients of an injection solutionis objectionable for several reasons. In the first place, bottles ofthis kind are more expensive to manufacture than my improved packagingcontainer, as will be made more clear later herein. Then, there is theeverpresent responsibility of establishing the identity of theingredients that go together in the preparation of a particularinjection solution. If the Wrong vehicle is used by mistake, there maybe serious results; if the bottle containing the proper vehicle becomesmisplaced, there will be failure of preparation possibly at a criticaltime. Assuming that the right bottles have been assembled, theoperational procedure of effecting a mixture of ingredients isinconvenient and timeconsuming, for each bottle must be picked up,penetrated and set down, as compared with much more simplifiedmanipulation when using my improved container. However, a disadvantageof a more serious nature is the necessity for removal of the syringeneedle from one bottle before penetration of the other. In suchhandling, there is great danger that air, which is usually dust and germladen, will enter the syringe needle and be injected into the medicamentbottle for intimate mixture with the otherwise sterile contents.

In the accomplishment of my purpose, I have provided a singlemulti-compartment container that somewhat resembles the cartridge orampule used as the internal component of the special type of hypodermicsyringe previously described,

but which is specifically intended for external use entirely in lieu ofthe two separate bottles that heretofore have been used to package theingredients for the common type of syringe. My improved unitarycontainer is so constructed that the complete operation of mixing therespective ingredients and charging the syringe reservoir with the finalinjection solution takes place while the needle of the syringe isprotectively shielded within the sterile compartments and contents ofthe container. No withdrawal of the needle in between steps of thecharge-preparing process is required.

Another object of the invention is to provide a multi-compartmentcontainer whose separate compartments or chambers are sealed againstintercommunication by a puncturable membrane composed of a material thatis non-toxic, nonfrangible, and in all respects meets the rigidrequirements imposed by the medical profession in the interest ofsterility and protection of the patient from accidental injection ofsolid substances into the blood stream. To be more explicit, I usepyroxylin as the material from which the membrane is made.

A further object is the provision of a novel and inexpensive method ofmaking and installing the pyroxylin membrane.

Other objects and advantages of the invention will become apparent asthe following specific description is read in connection with theaccompanying drawing, in which:

Fig. l is a side elevation of the container when loaded with theingredients for a hypodermic injection solution;

Fig. '2 is a longitudinal cross-sectional view of the same, showing thecontainer being held between the fingers and with the needle of asyringe about to be inserted through the end cap into the compartmentcontaining the solvent vehicle;

Fig. 3 is a similar view, showing the position of the needle afterinsertion into the solvent vehicle compartment and during back-suckingof the solvent vehicle;

Fig. 4 is a similar view, showing the position 7 of the needle aftersubsequent penetration of the membrane that intervenes between the twocoinpartments, after mixing of the ingredients in the medicamentcompartment, and during backsucking of the injection solution chargetherefrom;

Fig. 5 is a similar view after complete evacuation of both compartmentsand withdrawal of the needle therefrom;

Fig. 6 is a transverse cross-sectional view on line 6-6 of Fig. l; and

Fig. '7 is a similar view on line 1-1 of Fig. 1.

Referring in detail to the drawing, wherein like reference characters,designate corresponding parts in the several views, it will be observedthat the body I ll of my improved compartmented packaging container isin the general form of an' open-ended tube. Obviously, container bodiesof this simple form may be produced with great facility by cutting along stock tube of suitable material into sections of the requiredinitial length. The advantage of this feature in the adaptation of myinvention to low cost quantity production processes should be apparent.

As to the material from which container bodies I6 are made, glass hasbeen chosen because it possesses certain qualities that are verydesirable. Glass can be modeled readily when softened by heating, so thetubular body I0 may be modified in structural form, for a purpose whichwill appear presently, by resort to well known glassworking technique.Glass also is chemically inert in relation to the intended contents ofthe container and is transparent. These three qualities are enough tomake glass preferable, although it is to be understood that any othermaterial that meets the requirements may be substituted withoutdeparting from the scope of the invention.

Since the primary use for which I have devised my packaginge containerinvolves the separate confinement of only two ingredients, theillustrative embodiment of the invention appearing in the drawing hasjust two compartments. However, I do not intend to be restricted to anyparticular number of compartments. In the present instance, a medialwall I I partitions body IE into compartments I2 and I3.

Although partitioning wall II may have some other form, I prefer thespecific structure shown in the drawing, because it is easily formed byglass-working treatment without weakening body It] at the wall location.Furthermore, it is practicable by the same treatment to provide acentral through passage I4 of just the desired opp0- sitely flaringshape and also to provide a shallow external depression or groove I5 ofannular form surrounding wall II for finger engagement to facilitatefirm grasp on the container during the intended operational manipulationwhich will be described later.

The glass-working method by which the precise desired structure ofpartitioning wall I I, passage M and finger groove I5 is achieved isvery simple. The initial length of each tube section must be greaterthan the final length of container body I9 due to axial shrinkage thatoccurs in the course of the re-working treatment. Each tube section isgrasped at both ends and held with its central portion exposed to theflame of a Bunsen burner. l/Vhile heat is being applied, the tubesection should be rotated in the fingers so that it will be heateduniformly around its periphery. When it appears that the mid-portion issoft enough for modeling, the ends are first pulled axially outward toconstrict the central portion of the bore and at the same time formexternal groove I5. The glass worker then removes the tube section fromthe flame, and blows through the bore to chill the constricted portionand prevent excessive constriction. He then looks through the bore todetermine the degree of contraction and re-applies the flame to themidportion. Care must be, taken during rotation of the tube section toavoid twisting of the plastic mid-portion. When the mid-portion is againsufiiciently soft, the ends of the tube section are pressed axiallyinward instead of the previous reverse pulling action. This treatmentcauses thickening of the wall II with smooth rounding of the flaringmouths of constricted passage I4 and at the same time causes furtherconstriction. After removal from the fiame, quick blowing through thebore, and a visual check for the second time, if passage I4 is not quitesmall enough, the heating, rolling, pressing, blowing and visualinspection steps are repeated until passage It. has attained the correctdiameter. That diameter should be slightly greater than the externaldiameter of the conventional hypodermic needle in order to afford properclearance for easy penetration. Having completed the formation of themid-portion of container body It), the latter is ready for applicationof additional partitioning means of an impervious but puncturablenature.

Before proceeding with description of the said additional partitioningmeans, it may be mentioned that the ends of body III are annealed by useof the Bunsen burner flame so that their edges will be slightly enlargedand rounded for more secure fit'within the puncturable closure caps I6that are to be used as closures for the outer ends of compartments l2and I3. Incidentally, while these caps I6 are essential components of myimproved container in its final packaging condition, I am not making anyclaim to invention of any particular cap structure. In order to besufiiciently durable in their exposed applied positions on the ends ofbody I0, these caps I6 should be made of tough, elastic material such ashigh grade soft rubber or latex. The caps that have been used for theindividual bottles that my integral container is intended to 5 supersedemay be used. Consequently, it undoubtedly will be the practice toprocure the caps ready-made to fit the ends of my container body ID froma subvendor.

In further reference to the specific structure of partitioning wall IIas given to it by the glass working method described, it may be pointedout that the container body I has thereby been increased in strength atthe location where firm finger pressure is intended to be applied.Finger groove I is so shallow that the strength of the central handleportion of container body I0 is not impaired, but is deep enough toresist lengthwise slipping out of the finger grasp during the moststrenuous operational manipulations that may be involved in the mixingof ingredients by cooperative use of a hypodermic syringe.

Another important feature is the smoothly rounded, oppositely flaringform of passage when viewed in axial section. This form presents aguiding surface for smoothly directing the point of a hypodermic needleinto and through the narrow medial part of passage I4 without any dangerof bending, blunting or otherwise rendering the needle point unfit forthe delicate purpose for which it is intended, and, conversely, withoutdanger of glass fragments being chipped off the wall by the needlepoint. Further advantages will appear presently.

The partitioning of container body I0 is completed by provision of asealing membrane II that covers one end of passage I4. This membrane I1is intended to interrupt communication between compartments I2 and I3temporarily pending intermingling of the ingredients confined therein.The rubber or like material usually adopted for the manufacture ofimpervious, puncturable closure caps, such as those used in connectionwith the superseded bottles and which are suitable for use as caps I6 ofmy container, probably would be satisfactory for construction of mysealing membrane except for the impracticability of installing amembrane of that material in the required interior location. What seemedfor a long time to be an insuperable problem was finally solved, afterexhaustive experimentation with various materials and methods ofapplication, by my discovery that pyroxylin, a material that meets allthe strict medical requirements, could be used in the formation andinstallation of a perfectly satisfactory sealing membrane when pursuinga novel method that I devised. Pyroxylin meets the requirements becausein its solid state it is elastic, flexible, nonfrangible, non-toxic,inert, leak-proof, non-absorbent, easily needle-penetrated, and highlyadhesive to glass. Furthermore, it is admirably suited to my method whenin solution in ether or other highly volatile solvent in the form knownas collodion, because of its inherently adhesive quality in this stateand tendency to adhere tenaciously to a glass surface uponsolidification after being deposited thereon.

In accordance with the successful method that developed from myexperiments, each tubular body I0 preferably is first prepared bygrinding the side of wall II that is to receive application of themembrane I'I so as to abrade the naturally smooth surface and make itrough, as at I8 in the drawing, to form an anchoring face. It does notmake any difference which side face of wall II is abraded, because bothside faces and both flaring mouths of passage I4 are alike, but it maybe pointed out that it is preferable to confine the liquid vehicle inthe compartment that is directly faced by membrane I! so that pressureof the liquid, which is subject to surge, will not tend to loosen themembrane from its anchorage to wall II. It is for that reason thatmembrane I1 is shown in the drawing as being on the side of wall II thatfaces compartment I2.

The grinding tool (not shown) that is used to abrade wall II should betapered in order to extend anchoring face I8 into the flaring mouth ofpassage I4. After anchoring face I8 and the entire inner surfaces ofbody II) have been tho-roughly cleaned to insure removal of all glassparticles produced by the grinding operation, the said body is caused tostand on end, or otherwise supported in a position with its longitudinalaxis vertical and with compartment I2 uppermost. Then, a fairly largedrop of collodion is deposited on the upper face of wall I I This isaccomplished preferably by releasing the drop at a point directly aboveand in line with the upper mouth of passage I4. In either case, the dropwill be guided into a perfectly centered position by the said mouth, dueto its form and disposition. The size of the collodion drop should besuch that its diameter exceeds that of passage I4 at its most narrowpart and preferably equals the maximum diameter of the anchoring faceI8.

When the collodoin drop is deposited on anchoring face I8, it willpenetrate all indentations of the roughened surface. Due to theinherently highly adhesive nature of collodion, the drop will adhere toanchoring face I8 with such tenacity that it will not slip throughpassage I4. Actually, satisfactory adhesion will occur even if the mouthof passage I4 is left smooth instead of being roughened, but it ispreferred to have it roughened. As the ether solvent evaporates,shrinking of the drop will take place and the central portion will saguntil the previously substantially spherical drop has become a thin,parallelsided sheet of pure solid pyroxylin in the concavo-convex formshown. Because of the behavior just mentioned, collodion may be termedself-adhering.

After the drop of collodion has been deposited on anchoring face I8, allthat remains to be done under my method is to maintain body II] in itsvertical position until the ether solvent has evaporated sufficiently tocause membrane I! to become stabilized or set in its sheet-like form. Inquantity production in a processing machine (not shown), the requiredtime for evaporation should transpire during progress of each containerbody on a movable conveyor from the drop releasing station to thedischarge outlet for the finished container body.

While the above-described method is preferred, it is to be understoodthat I claim to be the originator of a pyroxylin membrane regardless ofthe precise method of production and installation. Other practicalmethods may be evolved within the scope of my invention, such, forexample, as cutting circular discs from a sheet of pyroxylin andapplying them to the walls of container bodies II] in closing relationto passages I4, which I have tried and found to be practical but notnearly so good as the collodion drop method. When applying cut pyroxylinmembranes, each one must be centered in position by means of a holdingdevice and the mid-portion of body II) must be heated in order to causesoftening of the applied face of the membrane disc. Otherwise, the discwill not adhere to the glass anchoring face I8. The collodion dropmethod is far superior to the alternative method just mentioned. Fromthe foregoing description of the various paztsof my unitary packagingcontainer in its illustrative two-compartment embodiment, theoperational use thereof in the preparation of an injection charge for ahypodermic syringe may be readily understood. Referring again to Figs. 1to 5 of the drawing in particular, it will be observed that compartmentsI2 and I3, respectively, have been loaded with a solvent vehicle 8 andmedicament M in precisely the correct proportions for a prescribedhypodermic injection. Caps I6 seal the outer ends of compartments I2 andI3 against external leakage and membrane ll seals passage 14 against anyleakage of solvent vehicle S from compartment I2 into compartment I3.

Assuming now that it is desired to mix the ingredients, the doctor ornurse will grasp the handle portion of container body In between fingersF of one hand in the manner shown in Figs. 2 to 5. With the other hand,the needle N of hypodermic syringe H is directed toward the thinpuncturable center of cap l6 for compartment l2 and moved in thedirection of the arrow in Fig. 2 until the said cap has been puncturedand needle N has penetrated compartment l2. When needle N is in thegeneral position shown in Fig. 3, the plunger (not shown) of syringe His operated to suck the entire contents of compartment l2 into thesyringe reservoir. In so doing, oscillation of container body l aboutthe transverse axis of its handle portion may be necessary. This actionis readily accomplished by simply rotating the wrist of the hand that isholding the container.

The next step is to press needle N further inward until membrane I! hasbeen penetrated and the needle point is in the general position shown inFig. 4 projecting into compartment [3. The provision of external fingergroove l5 at the handle portion makes it very easy to resist the thrustof needleN. Now, the vehicle S is forced from the syringe reservoirthrough needle N into compartment I3 for mixing with medicament M, whichmixing may be expedited by shaking the container and rocking it aboutthe said transverse handle axis. This agitating motion, of course, isimparted to both the container and syringe H in their united conditiondepicted in Fig. ll After thorough mixing has been accomplished, the

syringe needle N is withdrawn completely from the container as indicatedby the arrow in Fig. 5, thereby leaving the container body ii] in acompletely evacuated condition but in its original serviceable conditionexcept for the needle perforation 19 in membrane l1. Caps 16 also havebeen perforated, but they are replaceable and it is practicable torestore body IE] to serviceable condition in every respect by removingmembrane [1, sterilizing the said body, and applying a new membrane,preferably by the collodion drop method previously described. Containerbody ID with its strong partitioning wall II is far more durable thanthe bottles that I have undertaken to supersede, so my container iscapable of re-use if desired.

It is to be noted that, during the entire operation of mixing theingredients and charging the hypodermic syringe with the final injectionsolution, the needle of the syringe has not been withdrawn from thesterile interior of the container. It is in consequence of thisimportant feature of my container that the danger of contamination ofthe injection charge has been reduced to a minimum. Certainly, thedanger is far less than in the use of the two-bottle ingredientpackaging facilities.

Having thus described my invention, I claim:

1. As a new article of manufacture, a tubular body for a unitarycontainer for separately packaging the related ingredients of ahypodermic injection charge prior to intermixture, a partitionirig walldividing said body into adjoining compartments for reception of therespective ingredients, said wall havingan oppositely flaring throughpassage for penetration of a hypodermic needle, and a puncturablesealing membrane in the form of a concave-convex disc disposed inclosing relation to one side of the partitioning wall with its convexface contiguous to the said wall and bearing against the flaring mouthof the said passage in the wall, the marginal portions of the sealingmembrane being adhesively affixed to the wall and the mouth of thepassage.

2. A new article of manufacture as defined in claim 1, wherein thesealing membrane is composed of pyroxylin.

3. The method of producing and installing the sealing membrane for atubular packaging container of the class described which consists inapplying a drop of collodion to the interior of said container inmarginal contact with the glass body thereof.

4. The method of producing and installing the sealing membrane for thethrough passage in the partitioning wall of the tubular body of acompartment-ed packaging container of the class described which consistsin applying a drop of collodion to the partitioning wall in closingrelation to the passage therein.

5. The method of producing and installing the sealing membrane for thethrough passage in the partitioning wall of the tubular body of acompartmented packaging container of the class described Which consistsin disposing the container body with its longitudinal axis substantiallyvertical, depositing on the partitioning wall in closing relation to thepassage a drop of collodion, and maintaining the container in itsvertical position until the solvent for the pyroxylin base ofthecollodion has evaporated sufiiciently for the membrane to beself-sustaining in symmetrical form.

6. The method of producing and installing the sealing membrane for theflaring mouth of the through passage in the partitioning Wall of thetubular body of a compartmented packaging container of the classdescribed which consists in disposing the container body with itslongitudinal axis substantially vertical, depositing on the partitioningwall in closing relation to the passage mouth a drop of collodion of asize exceeding the diameter of the said mouth, and maintaining thecontainer in its vertical position until the solvent for the pyroxylinbase of the collodion has evaporated sufficiently for the membrane to beself-sustaining in symmetrical form.

7. The method as defined in claim 5, wherein the face of the wall towhich the collodion drop will adhere is roughened preceding the dropdepositing step. 8. The method as defined in claim 6, wherein the mouthof the flaring passage to which the collodion drop will adhere isroughened preceding the drop depositing step.

9. As a new article of manufacture, a tubular glass body for acompartmented container adapted to separately package the relatedingredients of a hypodermic injection charge, and a partitioning wallformed in said body integral therewith and having an axial throughpassage, said wall being constructed of substantially the same axial andradial thickness whereby the body is reinforced in strength in theregion of said passage.

10. A new article of manufacture as defined in claim 9, wherein the wallpassage is oppositely flaring with mouths smoothly rounded in an axialplane.

11. A new article of manufacture as defined in claim 9, wherein thetubular body is provided with a shallow annular peripheral finger groovesurrounding the partitioning wall to form a handle portion.

12. A unitary container for separately packaging the related ingredientsof a hypodermic injection charge prior to intermixture comprising anopen-ended tubular body, a partitioning wall dividing said body intoadjoining compartments for reception of the respective ingredients, saidwall having a through passage for penetration by the needle of ahypodermic syringe, a puncturable sealing membrane marginally afiixedadhesively to the partitioning wall in closing relation to the saidpassage, said sealing membrane being composed of pyroxylin solidifiedfrom an original deposit of collodion, and puncturable closures for theopposite ends of the said body.

13. As a new article of manufacture, a tubular body for a unitarycontainer for separately packaging the related ingredients of ahypodermic injection charge prior to intermixture, a partitioning wallintegral with said body and dividing the same into adjoiningcompartments for reception of the respective ingredients, said wallhaving a through passage for penetration of a hypodermic needle, and apuncturable sealing membrane marginally affixed adhesively to thepartitioning wall in closing relation to said passage, said sealingmembrane being composed of pyroxylin solidified from an original depositof collodion.

14. As a new article of manufacture, a tubular body for a unitarycontainer for separately packaging the related ingredients of ahypodermic injection charge prior to intermixture, a parti-. tioningwall integral with said body and dividing the same into adjoiningcompartments for reception of the respective ingredients, said wallhaving a through passage for penetration by a hypodermic needle andbeing constructed to flare outwardly toward one compartment of thetubular body, and a puncturable sealing membrane marginally affixedadhesively to the partitioning wall in closing relation to said passage,said sealing membrane being composed of pyroxylin solidified from anoriginal drop of collodion deposited upon the side of the partitioningwall through which the flaring end portion of the passage therein openswhile the tubular body is disposed in a vertical position with saidflaring passage portion directed upward and thereby is concavo-convexand in closely adhered conformation to said flaring passage portion.

15. In a container of the class described, a hollow body having a wallprovided with a through passage for needle penetration, and apuncturable sealing membrane marginally affixed adhesively to the bodywall in closing relation to said passage, said sealing membrane beingcomposed of pyroxylin solidified from an original deposit of collodion.

GEORGE H. SEEMAR.

REFERENCES CITED The following references are of record in the file ofthis patent:

UNITED STATES PATENTS Number Name Date 1,152,249 Wells Aug. 31, 19151,929,616 Vopata Oct. 10, 1933 2,175,365 Saflir Oct. 10, 1939 2,313,483Smith Mar. 9, 1943 2,444,532 Richardson July 6, 1948 2,445,477 FolkmanJuly 20, 1948

